Mike Loveless

Why qualitative research for medical device design?

qualitative research for medical deviceThe value of qualitative research in a highly regulated industry

When designing medical devices, it is important to remember that, just like consumer products, the devices we are creating interact with humans. They will be used by humans, on humans. Aspects of design like comfort, perception, behavior, information communication, all play a role in creating this interactive experience.   It is safe to say that human behavior and perception is not calculable or quantitative.  This requires us to employ qualitative research for medical device design studies and techniques.

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Alex Gunson

5 LEAN Manufacturing Techniques for Medical Device NPI

LEAN Manufacturing Techniques for Medical Device NPIWaste in manufacturing drives up product costs affecting both short term profitability and the long-term adoption curve. LEAN Principles that reduce waste are widely adopted to improve high volume manufacturing, but how can they be applied to New Product Introduction (NPI) for medical devices?
This blog shows how applying these 5 LEAN Manufacturing Techniques for Medical Device NPI can help to ensure a smooth and successful product launch.

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Vanessa Del Castillo Faria

Supply Chain Reports that keep your eye on the ball

 Supply Chain ReportsHaving overcome the challenges of transferring a product design into manufacturing, it is time to enter a new process cycle. At this stage, Supply Chain Reports are essential to assess and monitor costs, processing and material flow.
Supply Chain Reports can be a great source of data, providing insight into how processes are going, and enabling decision makers to find the right way to increase operational efficiency while remaining competitive.

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Astero StarFish

What’s the worst mistake you can make when developing a medical device?

worst mistake you can make when developing a medical deviceHow many have you made?

We posed the question, “What’s the worst mistake you can make when developing a medical device?” to our team of engineering, design, quality, regulatory and manufacturing experts. The answers were fast and furious (well, filled with enthusiasm) and in no particular order of importance, May you read and learn from our mistakes, a few from friends, and folks we consider family…

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Lorenzo Gutierrez

Top 10 COVID-19 Medical innovations

COVID-19 Medical innovationsRapid technological advancement is often triggered by external events such as international conflicts, political pressure, economic downturn, competitions or disease.  The COVID-19 pandemic has triggered the drive for technological advancement. Scientists, engineers and innovators have risen to the challenge by doing that which they do best – designing, building and prototyping.
Here are my top 10 COVID-19 medical innovations.

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Josh Coutts

Addressing ingress protection for home healthcare medical devices

Ingress Protection for Home Healthcare medical devices What the standard says and what you should know.

Increasingly medical device technology is filtering down from hospitals and into patients’ homes.  Designers need to understand and address the impact of this transition on the medical device design when addressing ingress protection for home healthcare medical devices
60601-1-11 Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment introduces additional IP requirements beyond those in 60601-1, that cover a larger classification of devices and may impact a home healthcare device.  These requirements are intended to protect patients and devices against the increased likelihood of liquid ingress in a home use environment and the associated risks such as electrical shock or impaired functionality.

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Hannah Rusak-Gillrie

Formative Evaluations and Tests, and When to Use Them

Formative Evaluations and TestsA critical component of Human Factors input during product design is evidence – based, user-centered feedback, gathered from conducting formative usability activities. We use two main approaches to gathering such feedback: Formative Evaluations and Formative Testing.  This blog details the differences between these methods, and the appropriate circumstances for their application.

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Tim Park

Tools and tips for holding COVID-19 friendly brainstorming meetings

Brainstorm Better Brainstorm Better with COVID-19 friendly brainstorming meetings

Just because your team is working from home due to COVID-19, doesn’t mean your ability to work collaboratively has to suffer.
Our design team has been working collaboratively between two offices on opposite ends of  Canada for more than three years now. Holding a meeting online might not seem as effective as holding one in person, but being able to have all participants at a computer actually offers a number of benefits.

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